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Faculty: José Mora


  • Date: 1/19/2021 01:00 PM - 1/19/2021 02:00 PM
  • Location: Online Event

Description

This Process Validation Requirements webinar will review process validation basics, with emphasis on looking beyond compliance towards achieving a robust process. Review of process validation basics, with emphasis on looking beyond compliance towards achieving a robust process. When used as intended, process validation can provide increased process reliability, improved yields, and reduced operating expenses.

Areas Covered in the Session :

  • Global Harmonization Task Force requirements (includes FDA and ISO)
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Design Qualification
  • Facilities and utilities
  • Strategies for achieving a robust and reliable process.
  • Typical process validation protocols

Who Should Attend:

  • Research and Development Departments
  • Engineering Departments
  • Quality Departments
  • Manufacturing Departments
  • Operations Departments
  • Production Departments
  • Document Control Professionals
  • Device Development Teams
  • Quality Auditors
  • Personnel involved in Verification and Validation planning, execution and documentation for devices